Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
Kowloon, Hong Kong
Location contact
Arnold YL Wong, PhD
CONTACT
Shahnawaz ANWER, PhD
CONTACT
Shahnawaz ANWER, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07391449
The aim of this trial is to conduct a 12-week randomised controlled trial comparing an HRV-guided home exercise program with traditional home exercise program for individuals with knee osteoarthritis (KOA), followed by 24-week assessment. The trial employs a validated HRV sensor and the HRV4Training app to record daily HRV measurements, enabling personalized exercise intensity adjustments. Participants with high HRV are prescribed high-intensity exercises, while those with low HRV undertake low-intensity exercises. In contrast, the traditional exercise group follows a standardised program, progressing from low to high intensity over the 12-week period.
The primary objective of this trial is to evaluate the effect of HRV-guided exercise on pain and functional disability in patients with KOA using validated outcome measures assessed at baseline, 12 weeks (post-intervention), and 24 weeks. Longitudinal semi-structured qualitative interviews at weeks 12 and 24 will explore participants' experiences and perceived barriers to exercise adherence. A mediation analysis will elucidate the physiological mechanisms underlying the efficacy of HRV-guided exercise. Secondary objectives include comparing HRV-guided and traditional home exercise programme in terms of exercise adherence, quality of life, sleep quality, self-efficacy, patient satisfaction, physical performance, balance, muscle strength, and lower limb biomechanics. Exploratory aims involve evaluating long-term effects (up to 24 weeks), examining associations between baseline HRV profiles and key outcomes, and determining the cost-effectiveness of HRV-guided exercise relative to traditional programme. The trial employs a robust methodological design, applying mixed-effects models and an intention-to-treat approach for data analysis.
Trial opening soon.
Get Notified45 year–70 year
All sexes
Interventional
Not applicable
Kowloon, Hong Kong
Arnold YL Wong, PhD
CONTACT
Shahnawaz ANWER, PhD
CONTACT
Shahnawaz ANWER, PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants in this group will follow the same exercise structure as the traditional home exercise group; however, their exercise program will be individualised according to daily HRV profiles. Exercise sessions will be performed three times per week for 12 weeks (36 sessions). All participants will conduct HRV measurements, starting one week before the intervention and continuing until its completion. HRV will be measured each morning immediately after awakening and bladder voiding, with participants remaining in the supine position for 5 minutes. The validated smartphone application, "HRV4Training" (http://www.hrv4training.com/) will be used to record HRV data [31]. The analysis provides the root mean square of successive differences between R-R intervals (root mean square successive differences [rMSSD]), derived via photoplethysmography. A 7-day rolling average (Ln rMSSD7d) will be computed, and HRV parameters will be calculated.
Participants in this group will measure their HRV daily as described in the next section; however, these HRV measurements will not be used to guide their exercise prescription. Instead, participants will follow a standardized home exercise programme, conducted three sessions per week for 12 weeks (36 sessions). Each session will include a 5-10-minute warm-up, a main exercise component comprising aerobic, strengthening, and stretching exercises (e.g., stretching of lower extremity muscles including knee extensors, knee flexors, and calf), and a 5-minute cooldown [27-29]. The warm-up phase will comprise mobility exercises designed to activate the lower extremity muscles, particularly the quadriceps and hamstrings, while the cool-down will incorporate stretching the muscle groups engaged during the session.
Time frame: change from pre- to post-treatment (12 weeks)
Assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. Higher scores mean more discomfort. The WOMAC pain subscale include five items for pain (scores range from 0 to 20).
Time frame: Change from pre- to post-treatment (12 weeks)
Assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale. Higher scores mean more difficulty with daily tasks. The WOMAC function subscale include 17 items for functional restriction (scores range from 0 to 68).
Time frame: week 12 and week 24
Client service recipient inventory (CSRI) will utilised to assess healthcare resource utilisation.
Time frame: week 12 and week 24
Quality-adjusted life-years (QALYs) will serve as outcome metric for economic evaluation, derived from the 5-level EuroQol instrument (EQ-5D-5L). Unadjusted mean costs and cost differences between HRV-G and TRD-G exercise groups will be examined for aggregate and disaggregated cost components, including intervention costs, healthcare service use, and pharmaceutical expenditures. Total cost differences (ΔC) and effect differences (ΔE) will be estimated, adjusting for baseline demographic and health characteristics. Responses from the EQ-5D-5L will be converted into utility scores, which will then be used to calculate QALY changes over the study period. The incremental cost-effectiveness ratio (ICER) will be computed using the formula ICER = ΔC/ΔE.
Time frame: changes from baseline to week 24
Assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. Higher scores mean more discomfort. The WOMAC pain subscale include five items for pain (scores range from 0 to 20).
Time frame: changes from baseline to week 24
Assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale. Higher scores mean more difficulty with daily tasks. The WOMAC function subscale include 17 items for functional restriction (scores range from 0 to 68).
Time frame: Baseline, week 12, week 24
The Arthritis self-efficacy scale (ASES) consists of 20 items that assess a patient's confidence in controlling pain, physical function, and other disease-related factors. The scale has three parts: pain management, function, and other symptoms like fatigue. Each question asks the respondent to rate their self-efficacy on a scale from 10 to 100, with 10 meaning "very uncertain" and 100 meaning "very certain" about their capacity to do particular tasks or deal with symptoms. Therapists give the questionnaire to patients and tell them to think about how confident they usually feel during the past week when they answer. To get subscale scores, the scores in each domain are added together. Higher scores indicate greater perceived self-efficacy.
Time frame: Baseline, week 12, week 24
The Pittsburgh Sleep Quality Index (PSQI) used to measure the quality and patterns of sleep in adults. It identify sleep quality between "poor" and "good" sleep by utilizing seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. A lower PSQI score indicates better sleep quality, with scores of ≤5 considered good and ≥5 indicating poor sleep quality.
Time frame: Baseline, week 12, week 24
The Center for Epidemiologic Studies Depression Scale (CESD) is a widely used self-report scale designed to measure depressive symptoms in the general population, consisting of 20 items that assess how often individuals have experienced specific symptoms over the past week. The score is the sum of the 20 questions. Possible range is 0-60. A score of 16 points or more is considered depressed.
Time frame: Baseline, week 12, week 24
The Patient Specific Functional Scale (PSFS) is a self-reported valid, reliable, and responsive outcome measure for patients with back, neck, knee and upper extremity problems. It has also been shown to have a high test-retest reliability in both generic lower back pain and knee dysfunction issues. It is also clinically responsive to changes over time with chronic pain patients. Patients are asked to identify up to five important activities they are unable to perform or are having difficulty with as a result of their problem eg putting socks on, shopping. Patients are asked to rate their current level of difficulty associated with each activity on an 11-point scale from 0 (unable to perform) to 10 (able to perform at prior level). Higher the score better the function.
Time frame: changes from baseline to week 12
The 30 second chair stand test (30sCST) requires participants to rise fully from a seated position in an unarmed, straight-backed chair (seat height: 45 cm) and return to a seated position until fully seated. The total number of chair-stand repetitions performed within a 30-s interval will be recorded. Participants will engage in two slow-paced practice repetitions prior to formal testing to ensure comprehension.
Time frame: changes from baseline to week 12
The 40-m fast-paced walk test (40MFPW) requires participants to walk as quickly and safely as possible along a 10-m walkway, turning around a cone positioned 2 m beyond each end of the walkway, resulting in a total distance of 40 m. Participants may utilize a walking aid if necessary, and the duration for task completion will be documented [22].
Time frame: changes from baseline to week 12
The stair-climbing test (SCT) will require participants to ascend and descend nine stairs, each with a step height of 20 cm, as quickly as possible while ensuring safety. A handrail will be provided for participants who wish to utilize it or require walking aids. The duration for participants to complete the ascending and descending tasks will be recorded.
Time frame: changes from baseline to week 12
Motion capture system will be utilized for gait assessment.
Time frame: changes from baseline to week 12
An isokinetic dynamometry will be used for the assessment of Quadriceps and Hamstring muscle strength
Time frame: changes from baseline to week 12
Bertec balance system will be used for the assessment of Single and double leg standing balance.
Time frame: Daily
All participants will conduct HRV measurements, starting one week before the intervention and continuing until its completion. HRV will be measured each morning immediately after awakening and bladder voiding, with participants remaining in the supine position for 5 minutes. The validated smartphone application, "HRV4Training" (http://www.hrv4training.com/) will be used to record HRV data [31]. The analysis provides the root mean square of successive differences between R-R intervals (root mean square successive differences [rMSSD]), derived via photoplethysmography. The rMSSD is preferred for its reliability over other HRV indices. To normalise data distribution, HRV values will be log-transformed using the natural logarithm (Ln) before statistical analysis. A 7-day rolling average (Ln rMSSD7d) will be computed, and HRV parameters will be calculated during both the familiarization period and on a weekly basis throughout the experimental phase.
Time frame: week 12
The feasibility and usability of the HRV device for optimising home exercise programme will be evaluated using the System Usability Scale (SUS). The HRV device will be considered a viable tool for rehabilitation and home exercise optimization in individuals with KOA if it achieves an average SUS score of 70 points or higher.
Contact information is provided by the study sponsor or research team.
Arnold YL Wong, PhD
CONTACT
Shanawaz Anwer, PhD
CONTACT
The Hong Kong Polytechnic University
Other
Heart Rate Variability Guided Optimization of Physical Activity and Exercise Prescription to Enhance Rehabilitation Outcomes in Individuals With Knee Osteoarthritis (HOPE-OA Trial)
Acronym: HOPE-OA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07649291
Arthritis, Behavior
Baltimore, Maryland, United States
View Trial DetailsNCT07210931
Arthritis, Behavior
View Trial DetailsNCT05173064
Arthritis, Behavior
Hong Kong
View Trial DetailsNCT07333690
Arthritis, Behavior
View Trial Details